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1 Policy briefHealth technology assessmentAn introduction to objectives, role of evidence, and structure in Europeby Marcial Velasco-GarridoReinhard Busse The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office forEurope, the Governments of Belgium, Finland, Greece, Norway, Spain and Sweden, the Veneto Region of Italy, the European InvestmentBank, the Open Society Institute, the World Bank, CRP-Sant Luxembourg, the London School of Economics and Political Science and theLondon School of Hygiene & Tropical policy brief is intended for policy-makers and those addressing the issue of Health technology Observatory on Health Systems and PoliciesThe views expressed by authors or editors do not necessarily represent the decisions or the stated policies of the European Observatory on HealthSystems and Policies or any of its partners.

2 The designations employed and the presentation ofthe material in this policy brief do not imply theexpression of any opinion whatsoever on the part ofthe European Observatory on Health Systems andPolicies or any of its partners concerning the legal status of any country, territory, city or area or of itsauthorities, or concerning the delimitation of its frontiers or boundaries. Where the designation country or area appears in the headings of tables,it covers countries, territories, cities, or areas. Dottedlines on maps represent approximate border lines forwhich there may not yet be full mention of specific companies or of certain manufacturers products does not imply that they areendorsed or recommended by the EuropeanObservatory on Health Systems and Policies in preference to others of a similar nature that are notmentioned.

3 Errors and omissions excepted, the namesof proprietary products are distinguished by initialcapital European Observatory on Health Systems andPolicies does not warrant that the information contained in this policy brief is complete and correctand shall not be liable for any damages incurred as a result of its use. World Health Organization 2005,on behalf of the EuropeanObservatory on Health Systems and PoliciesAll rights reserved. The EuropeanObservatory on Health Systems andPolicies welcomes requests for permission to reproduce or translateits publications, in part or in full(see address on inside back cover).

4 1 Health systems have developed at different speeds, and with differing degreesof complexity throughout the twentieth century, reflecting the diverse politicaland social conditions in each country. Notwithstanding their diversity, all systems, however, share a common reasonfor their existence, namely the improvement of Health for their entire popula-tions. To attain this goal a Health system undertakes a series of functions, mostnotably, the financing and delivering of Health available resources are limited, delivering Health services involves makingdecisions. Decisions are required on what interventions should be offered, the way the Health system is organized, and how the interventions should beprovided in order to achieve an optimal Health gain with available resources,while, at the same time, respecting people s thus need information about the available options and theirpotential consequences.

5 It is now clear that interventions once thought to bebeneficial have, in the light of more careful evaluation , turned out to be at bestof no benefit or, at worst, harmful to the individual and counterproductive tothe system. This recognition has led to the emergence of a concept known as evidence-based medicine , which argues that the information used by policy-makers should be based on rigorous research to the fullest extent possible(Ham et al. 1995).This policy brief introduces the concept of Health technology assessment ,which has been described as the speciality of assistance to Health policy-making (Jonsson & Banta 1999) by means of evidence, describing what isPolicy briefHealth technology assessmentAn introduction to objectives, role of evidence, and structure in EuropeThis policy brief is one of a series on Health care issues by the EuropeanObservatory on Health Systems and Policies.

6 This series is available online Policy brief Health technology Assessment3 Health technology assessment2 European Observatory on Health Systems and Policiesand to make it accessible and usable for decision-making purposes, in particu-lar by means of assessment reports. HTA shares these principles with evidence-based medicine (EBM) and clinical practice guidelines (CPG) and, togetherwith them, builds a body of best practice initiatives (Perleth et al. 2001).However, in contrast to HTA, which is policy-oriented, EBM and CPG aim tosupport decision-making at individual clinical level and patient group level,respectively.

7 The policy orientation of HTA has several implications. Assessments are conducted in response to, or anticipation of, a need for reliable information tosupport a decision, that is, at the origin of an assessment there is a decision tobe made. The types of decisions about which HTA can provide information aremultiple and may be located at different levels of the Health system and involvedifferent actors (politicians, hospital managers, Health civil servants, etc.).Assessments can be conducted in order to inform, for example, investment decisions (purchasing new equipment), or the shaping of the benefit catalogue(reimbursement of new services), as well as decisions concerning the organiza-tion of the service provision (implementation of rules for referral to specialists).

8 The information needs are in accordance with the type of decision and thelevel of decision-making; they also vary depending on the actors involved. Allthese contextual factors determine the scope of the assessment, that is, whichaspects of the technology or intervention are to be assessed, as well as the methodology to be applied, not least because of the financial or time constraints that may be imposed (Busse et al. 2002). For the purposes of HTA, the decision-maker s need for information is known as the policy question. Itsvarious dimensions are illustrated in Box 1 (overleaf).A policy question can be raised by the decision-maker her/himself.

9 However,institutions undertaking HTA often proactively identify areas where informationis likely to be needed in the future, perhaps through a process of horizon-scanning. Close cooperation between decision-makers and researchers is neededin order to clarify the underlying policy question and tailor the assessment tothe decision-maker s information needs. The quality of this interaction is one ofthe main determinants of the value of evidence for policy-making (Innvaer et ).Context-embeddedAs already mentioned, the context in which HTA research is carried out deter-mines the methods used and the extent and comprehensiveness of the assess-ment.

10 The scope and level of detail of HTA vary considerably, depending uponwho commissioned a study and why. It will not always be necessary to assessmeant by evidence. We then review the structures and institutions involved inhealth technology assessment at the European is Health technology assessment? Health technology assessment (HTA) has been defined as a form of policyresearch that systematically examines the short- and long-term consequences, interms of Health and resource use, of the application of a Health technology , aset of related technologies or a technology related issue (Henshall et al.)